Indications

Clear away pestilential pathogens, reduce inflammation and relieve fever. Used for common cold, fever, headache, running nose with clear nasal discharge and aching joints.

Usage and Dosage

For oral use. Take 3 to 4 tablets each time, twice a day.

Composition

Isatidis Folium, Lonicerae Japonicae Flos, Notopterygii Rhizoma et Radix, Bistortae Rhizoma, Rhei Radix et Rhizoma. Acetaminophen, Caffeine, Amobarbital, Vitamin C.

Character

This product is a film-coated tablet. After removing the coating, it appears brownish-black to dark brown. It has a faint smell and tastes bitter and astringent. 

Taboos

Those who are allergic to this product, as well as those who are allergic to amobarbital, paracetamol and caffeine, are prohibited from using it.

Patients with liver diseases such as ethanol poisoning, gastric ulcer, viral hepatitis and liver cirrhosis are prohibited from using it.

Those with severe pulmonary insufficiency, a history of asthma and those with renal insufficiency are prohibited from using it.

Those with a history of porphyria, anemia and diabetic patients with uncontrolled blood sugar are prohibited from using it.

This product is not suitable for patients with depression. 

Adverse Reactions

Skin and its appendages: Skin rash, itching, hyperhidrosis, purpura, itching, swelling and ulcers of the lips and genitals, etc. There are also literature reports of severe drug eruptions.

Digestive system: Dry mouth, nausea, vomiting, abdominal pain, diarrhea, abdominal distension, etc. There are also case reports of gastrointestinal bleeding and abnormal liver biochemical indexes.

Psychoneurological system: Drowsiness, insomnia, dizziness, headache, vertigo, etc.

Systemic reactions: Fatigue, malaise, anaphylactoid reactions, etc. There are also case reports of anaphylactic shock.

Others: Palpitations, chest tightness, dyspnea, edema, etc.

Long-term use of this product may lead to drug dependence, and withdrawal syndrome may occur after drug withdrawal.

Storage

Keep it sealed. 

The Period of Validity

36 months 

Warning

This product is a compound preparation of traditional Chinese and Western medicines,  containing chemical drug components such as paracetamol, amobarbital, caffeine, and vitamin C. Please read the instruction manual carefully and take the medicine under the guidance of a doctor. It is strictly prohibited to use it in food and feed processing. 

Cautions

This product is a compound preparation of traditional Chinese and Western medicines, containing chemical drug components such as paracetamol, amobarbital, caffeine, vitamin C, and the extract of Compound Isatis Indigotica Folium as the traditional Chinese medicine component. There is insufficient clinical trial data to confirm that this compound preparation can reduce or eliminate the toxicity and adverse reactions of its components. When using this product, attention should be paid to referring to the contraindications and precautions in the instruction manuals of paracetamol, amobarbital, and vitamin C.

Try to avoid using this product in combination with other drugs containing the same or similar components as this product to avoid drug overdose or synergistic toxic effects.

Both amobarbital and paracetamol, the components of this product, may cause rare but fatal skin adverse reactions. Approximately 1% to 3% of patients using preparations containing amobarbital may experience allergic reactions, mostly in the form of skin rashes and asthma. In severe cases, exfoliative dermatitis and erythema multiforme (or Stevens-Johnson syndrome) may occur, and toxic epidermal necrolysis is extremely rare. It has been reported that a very small number of patients using paracetamol may experience fatal and severe skin adverse reactions, such as exfoliative dermatitis, toxic epidermal necrolysis (TEN), Stevens-Johnson syndrome (SJS), and acute generalized exanthematous pustulosis (AGEP). If itching, skin rashes occur after taking the medicine, especially if erythema and erosion occur in the oral cavity, eyes, and external genitalia, stop taking the medicine immediately or follow the doctor's advice.

Avoid long-term or excessive dosing. Amobarbital and paracetamol may have a synergistic effect on hepatotoxicity. When necessary, pay attention to monitoring liver function. 

Cautions

Long-term use of preparations containing amobarbital may lead to psychological or physical drug dependence. When discontinuing the drug, the dosage should be gradually reduced to avoid withdrawal symptoms.

Those engaged in high-altitude operations, drivers, and workers in delicate and dangerous jobs should use this product with caution.

Those with an allergic constitution should use this product with caution.

Since this product contains paracetamol, the following should be noted:

(1) Cross-allergic reactions: It has been reported that among patients with asthma due to aspirin intolerance, a small number (<5%) may experience mild bronchospastic reactions after taking paracetamol.

(2) Avoid using in combination with other non-steroidal anti-inflammatory drugs (NSAIDs).

 (3) Patients with hypertension and/or heart failure (such as fluid retention and edema), or those with a history of hypovolemia or dehydration should use it with caution.

(4) Literature reports that long-term and excessive use of paracetamol by patients with renal insufficiency may lead to thrombocytopenia and liver damage, and even jaundice; it can further exacerbate renal function damage, and manifestations of renal failure such as oliguria and azotemia may suddenly occur.

(5) Interference with diagnosis: ① For blood glucose determination, a false low value may be obtained when using the glucose oxidase/peroxidase method, while there is no effect when using the hexokinase/6-phosphogluconate dehydrogenase method. ② For serum uric acid determination, a false high value may be obtained when using the phosphotungstic acid method. ③ For the determination of urinary 5-hydroxyindoleacetic acid (5-HIAA), a false positive result may be obtained when using the nitrosonaphthol reagent for the qualitative screening test, and the quantitative test is not affected.

Cautions

 (6) Pay attention to the drug interactions of paracetamol: ① Long-term alcohol consumption or the use of other liver enzyme inducers, especially patients using barbiturates or other antispasmodic drugs, increases the risk of hepatotoxic reactions when using paracetamol for a long time or in excessive amounts. ② When used in combination with aspirin, other salicylate preparations, or other non-steroidal anti-inflammatory drugs for a long time and in large amounts (such as a cumulative annual dose of 1000 grams for more than 3 years), it can significantly increase the risk of nephrotoxicity (including renal papillary necrosis, renal and bladder tumors, etc.). ③ Long-term or excessive use of paracetamol can reduce the synthesis of coagulation factors in the liver and enhance the effect of anticoagulants, so the dosage of anticoagulants should be adjusted according to the prothrombin time. ④ When taken together with chloramphenicol, it can enhance the toxicity of the latter. ⑤ When used in combination with the antiviral drug zidovudine, the binding effect with glucuronic acid may be reduced mutually, resulting in a decrease in clearance rate and an increase in toxicity, so simultaneous application should be avoided.

Since this product contains amobarbital, the following should be noted:

(1) Cross-allergic reactions: Those who are allergic to other barbiturate drugs may be allergic to this product.

(2) It may cause emotional changes and cognitive function disorders.

(3) When using preparations containing amobarbital, rare megaloblastic anemia and osteomalacia may occur; folic acid deficiency and hypocalcemia may occasionally occur during long-term medication; there are reports of hepatitis and liver function disorders.

(4) It is not advisable to use the drug for a long time. Rapid drug resistance may occur after continuous use for 14 days.

(5) Long-term use may lead to drug dependence, and withdrawal syndrome is likely to occur after discontinuing the drug.

(6) Use with caution in the following situations: hypotension, hypertension, anemia, hypothyroidism, adrenal insufficiency, and damage to the heart, liver, and kidney functions.

Cautions

(7) Pay attention to the drug interactions of amobarbital: ① Amobarbital is a liver enzyme inducer that increases the activity of drug-metabolizing enzymes, not only accelerating its own metabolism but also that of other drugs. When used in combination with paracetamol, it will increase the risk of liver poisoning. When used in combination with alcohol, general anesthetics, central nervous system depressants, or monoamine oxidase inhibitors, the effects of barbiturates can be enhanced mutually. ② When used in combination with oral anticoagulants, it can reduce the efficacy of the latter. The prothrombin time should be regularly measured, and the dosage of anticoagulants should be adjusted accordingly. ③ When used in combination with oral contraceptives, it can reduce the reliability of contraceptives, and when used in combination with estrogens, it can reduce the effect of estrogens. ④ When used in combination with corticosteroids, digitalis (including digoxin), oxytetracycline, or tricyclic antidepressants, it can reduce the effects of the above drugs. ⑤ When used in combination with cyclophosphamide, theoretically, it can increase the alkylation metabolites of cyclophosphamide, but its clinical significance is not yet clear. ⑥ When used in combination with quinidine, it can increase the metabolism of quinidine, and the dosage of the latter needs to be adjusted. ⑦ When used in combination with calcium ion antagonists, it can cause a drop in blood pressure. ⑧ When used in combination with haloperidol for the treatment of epilepsy, it can cause changes in the form of epileptic seizures, and the dosage needs to be adjusted; when used in combination with phenothiazines and tetracyclic antidepressants, it can reduce the convulsion threshold and increase the inhibitory effect. ⑨ When used in combination with ibuprofen, it can reduce or shorten the half-life and thus reduce the intensity of the effect. ⑩ When used in combination with other central nervous system depressants, attention should be paid to the synergistic inhibitory effect of the drugs on the central nervous system. 

Cautions

Since this product contains caffeine, the following should be noted:

(1) Occasional excessive intake of caffeine may cause nausea, headache, or insomnia. Long-term habitual excessive intake may lead to headache, nervousness, excitement, and anxiety.

(2) Excessive intake of caffeine can lead to restlessness, startle, tinnitus, blurred vision, and the appearance of blind spots or flashing lights, muscle tremors, increased heart rate, and premature beats. The lethal dose for adults is generally 10 grams, with a blood drug concentration of 60-160 micrograms per milliliter. There may be casts or red blood cells in the urine, and there are reports of death due to hepatic coma.

(3) Long-term and excessive intake of caffeine may lead to drug tolerance and also cause psychological dependence.

(4) Caffeine can increase the activity of renin in the plasma; it can slightly increase blood sugar.

(5) Pay attention to the drug interactions of caffeine: ① Most of the caffeine is metabolized by the liver, and it is metabolized through the isoenzyme CYP1A2 of cytochrome P450 in liver microsomes, and it can interact with other drugs and substances, enhancing or weakening their metabolic clearance. ② Isoniazid and meprobamate can enhance the efficacy of caffeine, increasing the concentration of caffeine in the brain tissue by 55% and decreasing the concentrations in the liver and kidneys. ③ Oral contraceptives may reduce the clearance rate of caffeine.

Cautions

Since this product contains vitamin C, the following should be noted:

(1) If vitamin C is taken in excessive amounts for a long time, the following adverse reactions are likely to occur: ① Taking 2-3 grams per day for a long time can cause scurvy after discontinuation of the drug. ② Long-term excessive intake may occasionally cause urate, cysteine, or oxalate stones. ③ Taking a large amount (more than 1 gram per day) can cause nausea, vomiting, stomach cramps, diarrhea, headache, red and shiny skin, and frequent urination (when the daily dosage is more than 600 milligrams). ④ Sudden discontinuation after long-term excessive intake may cause symptoms of scurvy.

(2) This product can pass through the placental barrier and be secreted into breast milk. When taken in excessive amounts by pregnant women, it can induce scurvy in newborns.

(3) Use with caution in the following situations: cystinuria, gout, hyperoxaluria, oxalosis, uric acid kidney stones, glucose-6-phosphate dehydrogenase deficiency, hemophilia, sideroblastic anemia or thalassemia, and sickle cell anemia.

(4) Taking a large amount will interfere with the following diagnostic tests: ① Occult blood in stool. ② Serum lactate dehydrogenase and serum transaminase. ③ Urine glucose (copper sulfate method), glucose (oxidase method). ④ Oxalate, urate, and cysteine in urine. ⑤ Serum bilirubin. ⑥ Urine pH.

(5) Pay attention to the drug interactions of vitamin C: ① When this product is used in combination with heparin or warfarin, it can shorten the prothrombin time. ② When used in combination with levodopa, it can reduce the efficacy of levodopa. ③ It can destroy vitamin B12 in food and chelate with copper and zinc ions in food to prevent their absorption, thus causing vitamin B12, copper, or zinc deficiency. ④ When used in combination with salicylates, barbiturates, or primidone, it can increase the excretion of vitamin C. ⑤ It is not advisable to use it in combination with sulfonamides. ⑥ Long-term or excessive use of vitamin C can interfere with the effect of disulfiram (Antabuse) on ethanol.

It is strictly prohibited to use this product in food and feed processing.